This phase I trial studies whether pafolacianine sodium (cytalux) works better than the standard approach at identifying cancer lesions that should be removed during surgery (intraoperative) in patients with gastrointestinal cancer that has spread to the abdominal lining (peritoneal carcinomatosis). Standard treatment for gastrointestinal cancer with peritoneal carcinomatosis includes chemotherapy and surgery to remove all visible tissue (cytoreductive surgery). Surgery is performed by identifying possible cancerous lesions on the abdominal lining using the naked eye (visual identification) and touch (palpation). Pafolacianine sodium is a molecule that attaches to specific receptors (like a lock and key) on tumor cells with an indocyanine green-like dye and acts as a tumor-imaging agent for intraoperative identification of cancerous lesions. Near-infrared fluorescent imaging uses wavelengths in the infrared range and is used with fluorescent dyes, such as pafolacianine sodium, for targeted imaging applications. Using pafolacianine sodium for intraoperative imaging may work better than the standard approach at identifying cancer lesions that should be removed during cytoreductive surgery for gastrointestinal cancer with peritoneal carcinomatosis.
Additional locations may be listed on ClinicalTrials.gov for NCT06511037.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer CenterStatus: Active
Contact: Maheswari Senthil
Phone: 714-509-2669
PRIMARY OBJECTIVES:
I. To describe the completeness of cytoreduction (CC) score with cytoreductive surgery (CRS) with cytalux trademark (pafolacianine) injection.
II. To evaluate the binding of cytalux trademark (pafolacianine) injection used with (near-infrared) NIR fluorescent light to accurately detect peritoneal carcinomatosis (cancer versus [vs.] non-cancer) in subjects undergoing cytoreductive surgery for gastrointestinal peritoneal carcinomatosis.
SECONDARY OBJECTIVES:
I. To evaluate the efficacy of cytalux trademark (pafolacianine) injection used with NIR fluorescent imaging to improve the detection of malignant tissue with regards to achieving at least one of the following outcomes in subjects scheduled to undergo surgical resection for known or suspected gastrointestinal peritoneal carcinomatosis:
Ia. One or more cancerous nodules not detected under normal light and/or palpation that is part of the surgical resection plan; or;
Ib. One or more cancerous nodules not detected under normal light and/or palpation that is not part of the surgical resection plan.
II. To characterize the rate of folate-receptor expression in cancers of gastrointestinal cancer and differentiate differences in folate-receptor expression in solid cancer lesions and peritoneal carcinomatosis.
EXPLORATORY OBJECTIVE:
I. To evaluate the proportion of subjects whose surgical procedure changed in scope from the planned surgery based on the use of cytalux trademark (pafolacianine) injection with NIR imaging.
OUTLINE:
Patients receive pafolacianine sodium intravenously (IV) over 60 minutes 4-24 hours prior to scheduled cytoreductive surgery. Patients then undergo cytoreductive surgery using normal light and palpation assessment. Patients also undergo near-infrared fluorescent imaging prior to and after standard of care surgical resection and may have additional lesions resected if deemed safe by the surgeon.
Lead OrganizationUC Irvine Health/Chao Family Comprehensive Cancer Center
Principal InvestigatorMaheswari Senthil
